Eye Sting
Outline: Comparative Eye Sting Study
Objective:

To determine if a "tear-free" claim can be substantiated for a product.

Subjects:

20 healthy volunteers

Timing:

1-day test
Start within 2 weeks of the time the test material is received

Quantity: 8 oz.

Methodology:
Clinical assessment by a Board Certified Ophthalmologist
Subjective assessment of pain

Procedures:
All subjects are examined by the Ophthalmologist for signs of irritation, redness and tearing. A trained technician then instills a drop of the diluted test article into one eye and a competitive control into the other eye of each subject. Each instillation takes place 5 minutes apart. After each instillation the subject evaluates the "sting" of each material based on a 6-point scale. The Ophthalmologist also examines each subject post-instillation for changes in irritation, redness and tearing. Range-finding studies with progressive increases in aqueous concentrations are also available.